India healthcare

Turbulent times for Indian R&D

AstraZeneca’s decision to shut its Bangalore R&D site coincides with a slide in the number of Indian clinical trials.

UK drugmaker AstraZeneca recently announced plans to shut its Avishkar research and development (R&D) site in Bangalore, which develops treatments for neglected tropical diseases, tuberculosis and malaria. The decision comes as part of the company’s broader restructuring strategy for its R&D operations, which was announced last year. Yet it may also exacerbate the tensions within India's clinical trials sector caused by a tightening of regulations.

The global restructuring of AstraZeneca's R&D operation mimics that of its larger UK rival GlaxoSmithKline. With a sizeable patent cliff and only partial success in refilling its pipeline, AstraZeneca plans to cut the size of its R&D operations in order to make them more efficient and productive. The aim is to focus in-house R&D on a handful of high-value areas such as oncology, cardiovascular disease and diabetes. The closure of the Bangalore R&D site confirms expectations that the company will shed many of its anti-infective research programmes, much to the dismay of emerging markets charities.

To counter some of the criticism that it is ignoring emerging needs in favour of developed market diseases, the company will continue development work on its phase II tuberculosis candidate AZD5847. It will also share its scientific insights into diseases, such asneglected tropical diseases and malaria, that areno longer covered by its research budget, by opening up itscompound library to partnerships. Nevertheless, the company is scaling back the commitment it made in 2012, along with 13 other global drugmakers, to wipe out or control 10 neglected tropical diseases by 2020, with support from the US, UAE and UK governments, as well as the Bill & Melinda Gates Foundation and the World Bank.

As well as the blow to public health, AstraZeneca’s decision to close its R&D operations in Bangalore will lead to the loss of 168 high-skill jobs in India. It also undermines government efforts to attract greater investment into the pharmaceutical and biopharmaceutical sectors. The loss will compound problems that have been caused by a cooling of investment sentiment towards the country as a low-cost base for clinical trials.

Clinical trial decline

The reason for that cooling investor sentiment is the new measures introduced to protect clinical trial subjects in India. As of September 2013, these require companies undertaking clinical trials to make audio and video recordings of the informed consent process, as well as obtaining written consent. Participants must also be fully aware of the possible risks of taking part.

The new regulations also mandate that test results are reported within 24 hours and that companies establish fair compensation packages in the event of the injury or death of a trial participant. All zonal offices of the Central Drugs Standard Control Organisation have established expert committees that must inspect clinical-trial sites at least once a year, as well as monitor study investigators more closely.

These requirements follow the deaths of some2,262 people in Indian trials over the past five years, according to the International Business Times, and were intended to answer fears that illiterate, vulnerable and poor people were being used as guinea-pigs. Patient groups and charities welcomed the new rules, and so too did many companies, at least initially. They now complain, however, that the stringent implementation of the rules has caused confusion, delayed approval processes, and extended the time it takes to conduct trials. The result is that India is no longer quite so attractive a market for drugmakers and contract research organisations keen to test their drugs.

Since the new regulations took effect, only five clinical trials have been given the go-ahead by the three new committees in charge of clearing studies. This compares with 325 trials in 2011 and 262 in 2012. The US National Institute of Health, one of the largest global funders of drug trials, has reportedly halted some 40 trials in India, while leading domestic drugmakers such as Biocon, Lupin and Piramal have moved trials to other countries, including some that are more expensive. Critics argue that this damages patients as well as businesses, depriving them of the chance to receive free treatment and gain access to new drugs.

AstraZeneca has not cited the new rules as a reason for its decision to abandon drug development in India. Global priorities are likely to have been a more important factor. Nonetheless, news of its research flight from India is likely to heighten existing anxiety in the industry. It may even prompt moves from the government to reignite interest in India as a destination for R&D and clinical trial investment.